U.S. patent number 11,400,015 [Application Number 16/312,524] was granted by the patent office on 2022-08-02 for kit comprising at least two bags.
This patent grant is currently assigned to Fresenius Medical Care Deutschland GmbH, Fresenius Medical Care Holdings, Inc., Fresenius Medical Care R&D (Shanghai) Co., Ltd.. The grantee listed for this patent is Fresenius Medical Care Deutschland GmbH, Fresenius Medical Care Holdings, Inc., Fresenius Medical Care R&D (Shanghai) Co., Ltd.. Invention is credited to Mingtao Gong, Richard Allen Lasher, Zhengxin Ma, Guangming Wu.
United States Patent |
11,400,015 |
Lasher , et al. |
August 2, 2022 |
Kit comprising at least two bags
Abstract
The present disclosure describes a kit for peritoneal dialysis
that includes at least two bags. The kit also includes an overwrap
for accommodating the at least two bags. At least one bag of the at
least two bags forms at least a portion of the overwrap. According
to the present disclosure, it is advantageously possible to reduce
the material consumption of the overwrap, lower the cost of the
kit, and reduce the amount of the disposable waste.
Inventors: |
Lasher; Richard Allen
(Farmington, UT), Wu; Guangming (Shanghai, CN),
Ma; Zhengxin (Shanghai, CN), Gong; Mingtao
(Shanghai, CN) |
Applicant: |
Name |
City |
State |
Country |
Type |
Fresenius Medical Care Deutschland GmbH
Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care R&D (Shanghai) Co., Ltd. |
Bad Homburg
Waltham
Shanghai |
N/A
MA
N/A |
DE
US
CN |
|
|
Assignee: |
Fresenius Medical Care Deutschland
GmbH (Bad Homburg, DE)
Fresenius Medical Care Holdings, Inc. (Waltham, MA)
Fresenius Medical Care R&D (Shanghai) Co., Ltd.
(Shanghai, CN)
|
Family
ID: |
1000006469691 |
Appl.
No.: |
16/312,524 |
Filed: |
June 29, 2016 |
PCT
Filed: |
June 29, 2016 |
PCT No.: |
PCT/CN2016/087780 |
371(c)(1),(2),(4) Date: |
December 21, 2018 |
PCT
Pub. No.: |
WO2018/000283 |
PCT
Pub. Date: |
January 04, 2018 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20190159967 A1 |
May 30, 2019 |
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
1/287 (20130101); A61J 1/10 (20130101); A61M
1/28 (20130101); A61M 1/282 (20140204) |
Current International
Class: |
A61J
1/10 (20060101); A61M 1/28 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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1185746 |
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Jun 1998 |
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CN |
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2647329 |
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Oct 2004 |
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1717258 |
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Jan 2006 |
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CN |
|
1893991 |
|
Jan 2007 |
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CN |
|
102481401 |
|
May 2012 |
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CN |
|
103429213 |
|
Dec 2013 |
|
CN |
|
203802866 |
|
Sep 2014 |
|
CN |
|
211536207 |
|
Sep 2020 |
|
CN |
|
H10-28720 |
|
Feb 1998 |
|
JP |
|
WO 97/41902 |
|
Nov 1997 |
|
WO |
|
WO 2004/069307 |
|
Aug 2004 |
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WO |
|
WO 2012/118060 |
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Sep 2012 |
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WO |
|
WO 2018/098806 |
|
Jun 2018 |
|
WO |
|
Other References
International Search Report and Written Opinion in Application No.
PCT/CN2016/087780, dated Mar. 29, 2017, 8 pages. cited by applicant
.
Intemnational Preliminary Report on Patentability in Application
No. PCT/CN2016/087780, dated Jan. 1, 2019, 4 pages. cited by
applicant .
Extended European Search Report in European Appln. No. EP
16906684.2, dated Jan. 30, 2020, 7 pages. cited by
applicant.
|
Primary Examiner: Wiest; Philip R
Attorney, Agent or Firm: Fish & Richardson P.C.
Claims
The invention claimed is:
1. A kit for peritoneal dialysis comprising: at least two bags
comprising: at least one solution bag configured to contain
peritoneal dialysis fluid for infusion; and a drainage bag
configured to receive used peritoneal dialysis fluid; and an
overwrap, wherein the drainage bag and a package film together form
the overwrap so that the at least one solution bag is enclosed by
the overwrap.
2. The kit according to claim 1, wherein the drainage bag stacks
over the solution bag, and wherein the package film covering the
solution bag from the bottom of the solution bag is bonded
hermetically to a periphery of the drainage bag.
3. The kit according to claim 2, wherein: (i) a patient connector
configured to establish a connection with a catheter, (ii) a first
transfer tubing configured to connect the solution bag with the
patient connector such that the solution bag and patient connector
are in fluid communication, and (iii) a second transfer tubing
configured to connect the drainage bag with the patient connector
such that the drainage bag and patient connector are in fluid
communication, are each disposed between the solution bag and the
drainage bag.
4. The kit according to claim 3, wherein the first transfer tubing
is connected to an outlet port of the solution bag via a frangible
connector.
5. The kit according to claim 4, wherein the catheter is configured
to be implanted in a patient.
6. The kit according to claim 3, wherein the second transfer tubing
is connected to an inlet port of the drainage bag via a linking
connector.
7. The kit according to claim 2, wherein at least one of the
solution bag, packaging film, or the drainage bag, is formed by a
film, wherein the film is extruded as a monolayer or multilayer
format.
8. The kit according to claim 1, wherein the solution bag stacks
over the drainage bag and is surrounded at least partially by the
drainage bag, and wherein the package film disposed adjacent a top
of the solution bag is bonded hermetically to a periphery of the
drainage bag.
9. The kit according to claim 8, wherein a patient connector
configured to establish a connection with a catheter, a first
transfer tubing configured to connect the solution bag with the
patient connector such that the solution bag and patient connector
are in fluid communication, and a second transfer tubing configured
to connect the drainage bag with the patient connector such that
the drainage bag and patient connector are in fluid communication,
are each sandwiched between the solution bag and the package
film.
10. The kit according to claim 9, wherein the first transfer tubing
is connected to an outlet port of the solution bag via a frangible
connector.
11. The kit according to claim 9, wherein the second transfer
tubing is connected to an inlet port of the drainage bag via a
linking connector.
12. The kit according to claim 1, wherein the material from which
the drainage bag is made differs from that of the solution bag and
of the overwrap.
13. The kit according to claim 1, wherein the material from which
the drainage bag is made differs from that of the solution bag or
of the overwrap.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application is the national stage entry of
International Patent Application No. PCT/CN2016/087780, filed on
Jun. 29, 2016, the disclosure of which is incorporated herein by
reference.
FIELD OF THE INVENTION
The disclosure relates to a kit comprising at least two bags, in
particular a kit for peritoneal dialysis.
BACKGROUND
Due to high flexibility and convenience, peritoneal dialysis is
used widely to treat kidney disease, chronic renal failure and
toxic disease. Peritoneal dialysis is a dialysis therapy which uses
a patient's peritoneum as a dialysis membrane, outstandingly
improves the quality of patients' daily life and prolongs their
residual renal function. By infusing a peritoneal dialysis fluid
(fresh dialysate) into the patient's peritoneal cavity through a
catheter implanted in the patient's body, osmosis and diffusion
occur across the patient's peritoneum between the plasma of the
patient and the peritoneal dialysis fluid. During peritoneal
dialysis, waste such as metabolites or toxic substances and excess
water diffuse from the plasma in the patient's capillary into the
peritoneal dialysis fluid across the patient's peritoneum. At the
same time, some substances which are required for normal
functioning diffuse from the peritoneal dialysis fluid into the
plasma in the patient's capillary across the patient's peritoneum.
After a period of time, the peritoneal dialysis fluid containing
waste and excess water is drained out of the patient's peritoneal
cavity through the catheter and the fresh peritoneal dialysis fluid
is then infused into the patient's peritoneal cavity through the
catheter. This process of emptying and filling is repeated
periodically to remove waste and excess water normally removed by
the patient's kidneys and to aid in the regulation of fluid and
electrolyte balance.
SUMMARY
In some embodiments, a kit includes at least two bags and an
overwrap for accommodating the at least two bags. The at least two
bags forms at least a portion of the overwrap.
The overwrap of the kit may consume less packaging materials and
thus results in less medical waste. Additionally, the overwrap may
improve heat penetration when the kit is sterilized after
packaging. Considering huge volumes of the kits consumed by PD
patients worldwide, the kit for peritoneal dialysis may lower the
cost for peritoneal dialysis treatment and therefore offers a more
affordable therapy.
These and other objects, features and characteristics, as well as
the methods of operation and functions of the related elements of
structure and the combination of parts and economies of
manufacture, will become more apparent upon consideration of the
following description and the appended claims with reference to the
accompanying drawings, all of which form a part of this
specification, wherein like reference numerals designate
corresponding parts in the various figures. It is to be expressly
understood, however, that the drawings are for the purpose of
illustration and description only and are not intended as a
definition of the limits of the invention.
BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 shows schematically a conventional kit for peritoneal
dialysis without an overwrap.
FIG. 2a is a side view showing the conventional kit for peritoneal
dialysis in a packaged configuration.
FIG. 2b is a top view showing the conventional kit for peritoneal
dialysis.
FIG. 3a is a side view showing a kit for peritoneal dialysis in a
packaged configuration.
FIG. 3b is a top view showing the kit for peritoneal dialysis.
FIG. 4a is a side view showing a kit for peritoneal dialysis
according to an alternative embodiment in a packaged
configuration.
FIG. 4b is a top view showing the kit for peritoneal dialysis
according to the alternative embodiment.
DETAILED DESCRIPTION OF THE FIGURES
FIG. 1 shows schematically a kit for peritoneal dialysis. The kit
may be used in Continuous Ambulatory Peritoneal Dialysis (CAPD). As
shown in FIG. 1, the kit for peritoneal dialysis comprises a
solution bag 1 filled with fresh peritoneal dialysis fluid for
infusion, a drainage bag 3 for receiving the used peritoneal
dialysis fluid drained out of the patient's peritoneal cavity, a
patient connector 5 for establishing connection with the catheter
implanted in the patient's body, a first transfer tubing 7 for
communicating the solution bag 1 with the patient connector 5, and
a second transfer tubing 9 for communicating the drainage bag 3
with the patient connector 5. Prior to being distributed to the
patient, the kit for peritoneal dialysis must be packaged and
sterilized to reduce potential patient infection and contamination
caused by foreign matters. Thus, the kit for peritoneal dialysis
further comprises an overwrap 10 within which the solution bag 1,
the drainage bag 3, the patient connector 5, the first transfer
tubing 7, and the second transfer tubing 9, are packaged.
FIG. 2a is a side view showing a conventional kit for peritoneal
dialysis in a packaged configuration, and FIG. 2b is a top view
showing the conventional kit for peritoneal dialysis. As shown in
FIGS. 2a and 2b, the overwrap 10 is in form of a pouch. The pouch
may be comprised of a single piece or multiple pieces of film that
are joined by a sealing process. The film(s) may be thermoformed
and sealed using a manufacturing process such as Multi-vac. FIG. 3a
is a side view showing a kit for peritoneal dialysis in a packaged
configuration, and FIG. 3b is a top view showing the kit for
peritoneal dialysis. As shown in FIGS. 3a and 3b, a kit for
peritoneal dialysis generally comprises a solution bag 11 filled
with fresh peritoneal dialysis fluid for infusion, an empty
drainage bag 13 for receiving used peritoneal dialysis fluid
drained out of the patient's peritoneal cavity, a patient connector
15 such as a Y-type luer connector for establishing connection with
a catheter (not shown) implanted in the patient's body, a first
transfer tubing 17 for communicating the solution bag 11 with the
patient connector 15, a second transfer tubing 19 for communicating
the drainage bag 13 with the patient connector 15, and an overwrap
21. The solution bag 11, the patient connector 15, the first
transfer tubing 17, and the second transfer tubing 19 are packaged
within the overwrap 21. The first transfer tubing 17 is connected
at one end to an outlet port 11a of the solution bag 11 via a
frangible connector 22. The transfer tubing is also connected to
the patient connector 15 at other end. The second transfer tubing
19 is connected at one end to an inlet port 13a of the drainage bag
13 via a linking connector 23. The second transfer tubing is also
connected to the patient connector 15 at other end. Preferably, the
solution bag 11 further comprises an injection port 11b for
injecting a supplementary liquid such as medicine or nutrient
solution into the solution bag 11.
The drainage bag 13 stacks over the solution bag 11. A package film
25 covering the solution bag 11 from the bottom of the solution bag
11 is bonded hermetically to a periphery of the drainage bag 13 by
a conventional process such as heat fusion. In this way, the
drainage bag 13 and the package film 25 covering the solution bag
11 together form the overwrap 21. Although in the embodiment shown
in FIGS. 3a and 3b the patient connector 15, the first transfer
tubing 17, and the second transfer tubing 19 are sandwiched between
the solution bag 11 and the drainage bag 13, the patient connector
15, the first transfer tubing 17, and the second transfer tubing 19
may be disposed between the solution bag 11 and the package film
25, or within a space 27 defined by the solution bag 11, the
drainage bag 13 and the package film 25.
FIG. 4a is a side view showing a kit for peritoneal dialysis
according to an alternative embodiment in a packaged configuration.
FIG. 4b is a top view showing the kit for peritoneal dialysis
according to the alternative embodiment. As an alternative, the
solution bag 11 stacks over the drainage bag 13 and the drainage
bag 13 is folded to surround partially the solution bag 11. The
package film 25 disposed adjacent the top of the solution bag 11 is
bonded hermetically to the periphery of the drainage bag 13.
Similarly, the drainage bag 13 and the package film 25 disposed
adjacent the top of the solution bag 11 together form the overwrap
21. Although in the embodiment shown in FIGS. 4a and 4b the patient
connector 15, the first transfer tubing 17 and the second transfer
tubing 19 are sandwiched between the solution bag 11 and the
package film 25, the patient connector 15, the first transfer
tubing 17 and the second transfer tubing 19 may be disposed between
the solution bag 11 and the drainage bag 13 or within a space 27
defined by the solution bag 11, the drainage bag 13 and the package
film 25.
The solution bag 11 and the drainage bag 13 are commonly made from
films composed of PVC or olefinic based polymers which commonly
contains a thermoplastic (e.g. polypropylene (PP)) and elastomer
(e.g. styrene ethylene butadiene styrene (SEBS)). The package film
25 is commonly made from materials composed of high density
polyethylene (HDPE), polypropylene (PP), or other olefinic based
polymers. Of course, to lower the cost, the material from which the
drainage bag is made may differ from that of the solution bag
and/or of the overwrap. These films forming the solution bag, the
drainage bag, and the package film can be extruded in mono-layer or
multi-layer formats. To integrate the drainage bag 13 with the
package film 25 to form the whole overwrap 21, the materials from
which the drainage bag 13 and the package film 25 may be selected
so that they not only satisfy the technical requirements from both
the drainage bag and the overwrap, but also are compatible with
bonding to each other to achieve an integrated design.
In use, the overwrap 21 and thus the package film 25, is torn off
and removed. The patient connector 15 is connected with the
catheter implanted in the patient's body. The used peritoneal
dialysis fluid drains out of the patient's peritoneal cavity and
flows into the drainage bag 13 through the patient connector 15 and
the second transfer tubing 19. The drainage bag 13 filled with the
used peritoneal dialysis fluid is removed. Then, the fresh
peritoneal dialysis fluid is infused into the patient's peritoneal
cavity from the solution bag 11 through the first transfer tubing
17 and the patient connector 15 by pinching a frangible point at
the frangible connector 22 to open the frangible connector 22.
After the fresh peritoneal dialysis fluid is infused into the
patient's peritoneal cavity, the patient connector 15 is
disconnected from the catheter implanted in the patient's body.
This process of emptying and filling is completed and the kit for
peritoneal dialysis is disposed as medical waste.
Although the drainage bag 13 forms the whole top of the overwrap 21
in the embodiment as shown in FIGS. 3a and 3b and the drainage bag
13 forms the whole bottom and the sides of the overwrap 21 in the
alternative embodiment as shown in FIGS. 4a and 4b, it should be
understood that the drainage bag 13 may occupy more or less portion
of the overwrap 21.
The drainage bag 13 forms a portion of the whole overwrap 21. As a
result, the material consumption of the package film 25, and thus
the amount of the disposable medical waste after treatment, may be
reduced. Further, due to the thinner thickness of the kit for
peritoneal dialysis, heat penetration during sterilization may be
increased, thereby further reducing the manufacturing costs of the
kit for peritoneal dialysis. Considering huge volumes of the kits
consumed by PD patients worldwide, the kit for peritoneal dialysis
as described herein ideally lowers the cost for peritoneal dialysis
treatment and therefore offers a more affordable therapy especially
for emerging market.
Although in the preferred embodiments only the drainage bag is
shown to form a portion of the overwrap, it is feasible that the
solution bag forms a portion of the overwrap or both the drainage
bag and the solution bag form a portion of the overwrap or the
whole overwrap. Further, in the preferred embodiments, the kit for
peritoneal dialysis comprises only one solution bag. However, other
solution other than peritoneal dialysis fluid may also be required
to infuse into the patient for some therapy. In such case, the kit
for peritoneal dialysis may comprise more than one solution bag.
Although in the preferred embodiments the kit is implemented as a
kit for peritoneal dialysis, it should be understood that the kit
may be any kit comprising at least two bags one of which forms a
portion of the overwrap of the kit whether at least one of the bags
is filled with liquid or not.
Although the invention has been described in detail for the purpose
of illustration based on what is currently considered to be the
most practical and preferred embodiments, it is to be understood
that such detail is solely for that purpose and that the invention
is not limited to the disclosed embodiments, but on the contrary,
is intended to cover modifications and equivalent arrangements that
are within the spirit and scope of the appended claims.
* * * * *